Clinical Safety Specialist I

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Minneapolis/ St. Paul, MN
$70,000 - $70,000
Job Type
Direct Hire
May 07, 2018
Job ID
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The Clinical Safety Specialist I coordinates and supports clinical study adverse event data collection, assessment, adjudication and analysis. 
Job Description:
  • Provide initial review, evaluation, and track incoming adverse events for assigned studies.
  • Escalate events as appropriate per study specific safety plan to designated recipients.
  • Assist in collaboration with Regulatory Affairs, Clinical Study Teams, and Medical Monitor on events requiring expedited review or reporting.
  • Work with Field Assurance to ensure timely reporting of AEs, SAEs and UADE’s, in accordance with applicable regulations and company procedures.
  • Support additional safety-related tasks (e.g. Medical Monitor reports for aggregate trend review and signal detection) as directed.
  • Ensure consistency and compliance in applications of definitions for adjudication outcomes across assigned studies as appropriate for the specified protocols.
  • Provide support in preparing and coordinating CEC / DMC / DSMB meetings, or working with CROs who oversee this function, as applicable.
  • Contribute to the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices.
  • Bachelor’s degree or equivalent experience.
  • At least 2 years of clinical research experience, ideally with 1 year clinical safety responsibilities.
  • Working knowledge of the pharmaceutical, biotechnology and/or medical device clinical trial data management and processes, including the regulatory requirements of 21 CFR Part 11, ICH-GCP, other relevant Guidance documents (ICH, FDA, EMA etc.).
  • Experience in cardiovascular field.
  • Familiarity with multiple EDC systems.
  • Knowledge and working familiarity of MedRA coding and safety management systems (eg. AERS, ARGUS) .
  • Working knowledge of medical terminology, acronyms, and ability to communicate effectively with medical personnel.
  • Strong Microsoft Office skills, including Excel, Word, and Power Point.

Identifier: $MEDD